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Browse English Issue Headlines - November 2006

Ethylene Oxide Sterilisation Validation: How Far Can the Validity of 'Piggy-Backed' Products be Stretched?

The term 'piggy-back' is being increasingly used in the medical device industry when referring to the addition of similar products, totally different products or the same products but in different primary packaging, to the scope of an existing ethylene oxide (EtO) validation study. The benefits are clear. Piggy-backing products onto a previous validation study, or onto a different manufacturer's validation study can avoid many expenses and lost time, and allow products to be fast-tracked to the market to meet customer needs and/or to stay ahead of the competition. It could be argued that most EtO validation studies conducted in compliance with BS EN 550 and ISO 11135 include a form of piggy-backing, in that products are often grouped into 'families', and a single device from each family is selected to represent the other members of that family. These selected products alone are seeded with biological indicators during the validation study. In essence, therefore, the remaining members of the family are piggy-backed on to the physical and microbiological results of the selected product. The question the author, David Pickard, explores in his article is: how far can piggy-backing be stretched before the minimum sterility assurance level of 10-6 required by the BS EN 556 standard to label a medical device as sterile becomes overwhelmed? More >>

Pre-IDE: a Flexible Process with Potentially Significant Return on Investment

If an IDE is the Investigational Device Exemption application that is submitted to the US Food and Drug Administration to request permission to study a medical device in humans, it would seem logical to assume that 'pre-IDE' is another application submitted before the IDE. It could also imply that a pre-IDE always comes before an IDE. This, however, is not the case. A pre-IDE is not a requirement for an IDE; in fact, a sponsor can utilise a pre-IDE even when no IDE is anticipated. Rather than limiting 'pre-IDE' to a document, a more accurate representation of 'pre-IDE' is that of a process that can consist solely of written correspondence with the Agency or it can be correspondence in conjunction with a meeting with the FDA. In her article, Rosina Robinson describes pre-IDE, the development of the pre-IDE process, the use of the process, the logistics, and considerations for making this flexible process one that can yield potentially significant returns on the sponsor's investment. The article includes information about a combined approach consisting of a pre-IDE submission and a face-to-face meeting. More >>

Drugs versus Devices: The Effect of Product Type on Clinical Data Characteristics & Collection Methods

To utilise data to obtain marketing approval of a product under US law, a multitude of distinctions become apparent between the drug and device development industries. The initial distinction becomes apparent at the statutory level as outlined by the Food and Drug Administration, the Agency responsible for review and approval of marketing of these products. As stated in a recent communication comparing the US drug and device regulations, 'Regulations are based on good science and should not be 'hurdles' or just for licensing'. To that end, the differences between drug and device development, which permeate to the 'collectors of data', must be clearly understood in order that we generate 'good science'. Alicia Pouncey's article outlines a few of the differences in the characteristics of data collection between drug and device clinical trials. Although regulatory requirements begin the distinction, the objective of her article is to highlight differences at the level of the clinical study site by discussing characteristics unique to the type of product under investigation and offering suggestions to improve the quality of the data collection process. More >>

The Dilemma of Medical Device Pricing in the USA: Using Value-Based Pricing to Support Product Positioning

Developing the 'right' price for a medical device is one of the most difficult decisions in the product development process. The various stakeholders in the medical technology arena hold conflicting views about pricing, based on their different economic incentives and social perspectives. Value-based pricing explicitly takes these perspectives into account to develop product pricing that is viable internally, yet defensible in a price-sensitive marketplace. In this article, Nancy L Reaven explains that by identifying the specific stakeholders for a new product, analysing their unique perspectives and addressing their concerns in the pricing strategy of a new product, medical device companies can make informed decisions about pricing that will result in strong sales and product adoption. More >>

European Update

  • Bulgaria's accession to the EU in 2007
  • EESC opinion on the MDD review
  • EU chemicals legislation
  • Parliamentary question: guidance on hip, knee and shoulder joint replacements
  • Legislative framework for new and emerging technologies
  • New French biomedical research fees
  • German health reforms
  • IMB increases fees for Certificates of Free Sale
  • Transfer of responsibility for AIMDs in Portugal
  • Swissmedic's recommendations for safe use of blood sugar measuring devices
  • UK Device Bulletin on blood pressure measurement devices
  • Medical Device Alert issued by UK MHRA
  • MHRA issues guidance on vigilance system for breast implants
  • External defibrillators used for cardiac arrest: safety tips from UK MHRA

More >>

US Update

  • User fees for fiscal year 2007
  • Submission of validation data for reprocessed single-use devices
  • Faecal calprotectin immunological test systems: classification
  • Heparin catheter lock-flush solutions: transfer of primary Center responsibility
  • FDA requests comments on unique device identification
  • FDA electronic submissions gateway now operational
  • Review of agreements, guidances and practices for combination products
  • Keratome and replacement keratome blades: guidance
  • Humanitarian Device Exemption regulation: guidance
  • Commercially-distributed ASRs: draft guidance
  • IVDMIAs: draft guidance
  • FDA forms task force on human tissue safety
  • FDA creates internal nanotechnology task force
  • AdvaMed's office has relocated

More >>


  • Responsibility for clinical studies in Argentina
  • Argentina publishes protocol for registration of medical products
  • Australian TGA fees and charges for 2006/7
  • Implementation of regulatory framework for IVDs delayed
  • Abridged assessments for previously registered or listed devices
  • Sterility testing of therapeutic goods: TGA guidance
  • Variants for Class III devices and AIMDs: draft Australian guidance
  • Brazil updates its restrictions on the re-use of medical devices
  • Administrative amendments to Canada's devices regulations
  • Classification keyword index: Canada issues updated guidance
  • Recognition and use of standards: Canada issues updated guidance
  • China introduces strict controls on devices containing materials of bovine or ovine origin
  • SFDA further intensifies adverse event surveillance
  • Introduction of centralised purchasing of medical devices by Chinese hospitals
  • New sampling and testing requirements to confirm device quality in China
  • Stricter controls introduced for device advertising in China
  • Hong Kong's Conformity Assessment Body Recognition Scheme launched
  • Trans-Tasman interim Ministerial Council meeting report
  • ANZTPA consultation process: an update
  • Latest GHTF documents
  • US signs TIFA with ASEAN
  • US/Oman Free Trade Agreement signed into US law
  • Confidentiality agreement signed between Netherlands and USA
  • Canada and USA to develop Pilot Multi-Purpose Audit Programme
  • Estimation of uncertainty of measurement in medical laboratories: EDMA Position Paper issued
  • Medical device reimbursement in Japan: background information
  • Peru proposes new requirements for medical devices
  • Saudi Arabia plans to introduce regulatory system for medical devices
  • Devices prohibited from importation into Thailand
  • Thai FDA's Notification on HIV-related products
  • Tighter controls on breast enlargement products introduced
  • New Thai regulations published for dental bleaching products
  • Vietnam's accession to the WTO and distribution market access

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Environment Update

  • Implementation of EU waste legislation
  • Directive published on batteries and accumulators
  • Hazardous substances in electrical and electronic equipment

More >>

Standards Update

  • Updated list of harmonised EU standards
  • US JCAHO launches Standards Improvement Initiative
  • NEMA issues quality control templates for x-ray imaging

More >>

Reference Information

  • Regulatory personnel on the move
  • Overview of regulatory environment for medical devices in Canada
  • Elemental Essentials: the EU WEEE and RoHS Directives plus a special supplement summarising WEEE legislation and compliance in the EU Member States
  • Conformity Assessment Procedures Part 3: Directive 98/79/EC
  • A comparison of post-market surveillance requirements in Australia, Canada, the USA, Japan and the EU

More >>